Study of Naltrexone for Methamphetamine Addiction | NCT00984360

Studies
Study of Naltrexone for Methamphetamine Addiction

NCT00984360

Sponsor

California Pacific Medical Center Research Institute

Status

Completed

Last Update Posted

May 31, 2013Estimated

Enrollment

22Actual

Phase

Phase 2

Conditions

Methamphetamine Dependence

Interventions

Naltrexone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Sep 2012Actual

First Submitted Date

Sep 14, 2009

First Submission Date that Met QC Criteria

Sep 24, 2009

First Posted Date

Sep 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2013

Last Update Posted Date

May 31, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research InstitutePrincipal Investigator

Lead Sponsor

California Pacific Medical Center Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether methamphetamine-dependent individuals will use less methamphetamine when treated with naltrexone. The study will also investigate whether individuals with the mu opioid receptor gene variant A118G will use less methamphetamine than individuals without A118G.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A118G	Experimental		Drug: Naltrexone
Wild-type	Experimental		Drug: Naltrexone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naltrexone	Drug	380mg extended-release, given once by intramuscular gluteal injection	A118G Wild-type

Measure	Description	Time Frame
MA (-) Urine Samples		Twice weekly for 5 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 50 years
Patient is agreeable to conditions of study and signs consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Mendelson, MD	California Pacific Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Addiction & Pharmacology Research Laboratory		San Francisco	California	94110	United States

Intervention Browse Module

MeSH Terms

ID	Term
D009271	Naltrexone
C000624616	vivitrol

Ancestor Terms

ID	Term
D009270	Naloxone
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571

Browse Leaves

Not provided

Browse Branches

Not provided